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510(k) K100230

SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V by Eleme Medical, Inc. — Product Code NUV

K100230 is an FDA 510(k) premarket notification submitted by Eleme Medical, Inc. for the device "SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V". The FDA issued a decision of Substantially Equivalent on Apr 2, 2010. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Eleme Medical, Inc. has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 2, 2010
Date Received
Jan 26, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Light Induced Heating
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type
510(k)

The device is intended to temporarily alter the appearance of cellulite

Other clearances by Eleme Medical, Inc.

  • K083478 — SMOOTHLIPO (Mar 17, 2009)
  • K083629 — SMOOTHSHAPES (Feb 19, 2009)

Other clearances for product code NUV

  • K261582 — Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) (Aug 28, 2026)
  • K231092 — T-SHAPE 2 (Sep 22, 2023)
  • K211272 — ICOONE Laser Med (also referred to as ICOONE Medical laser) (Jun 22, 2021)
  • K182453 — ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) (Jan 11, 2019)
  • K161892 — Slimming Treatment Device (Mar 2, 2017)
  • K131362 — INMODE WMBODY DEVICE (Oct 8, 2013)
  • K122579 — VELASHAPE (Sep 13, 2012)
  • K101147 — MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM (Jan 21, 2011)
  • K101366 — I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (Sep 17, 2010)
  • K092195 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (Oct 1, 2009)

FDA data resources